Registry of Patients With Plasma Cell Disorders (Registry PCD)

February 22, 2024 updated by: Chutima Kunacheewa, Siriraj Hospital

The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:

  • The incidence of plasma cell disorders both before and after malignancy
  • Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
  • Progression free survival (PFS)
  • overall survival
  • factors influencing overall survival, progression-free survival, and time to progression
  • Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.
  • genetic characteristics of plasma cell disorder
  • cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

plasma cell disorder patients

Description

Inclusion Criteria:

  • Both existing and newly diagnosed patients with plasma cell disorders, including monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, POEMS, light chain amyloidosis, solitary plasmacytoma, and multiple myeloma, according to the diagnostic criteria of the International Myeloma Working Group 2014
  • Aged 18 years and above

Exclusion Criteria:

  • insufficient data needed for analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
register the plasma cell disorder patients
Time Frame: 10 years
register the plasma cell disorder patients
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of plasma cell disorders
Time Frame: 10 years
incidence of plasma cell disorders both before and after malignancy
10 years
Time to progression
Time Frame: 10 years
- Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
10 years
Progression free survival
Time Frame: 10 years
Progression free survival
10 years
overall survival
Time Frame: 10 years
overall survival
10 years
influencing factors
Time Frame: 10 years
factors influencing overall survival, progression-free survival, and time to progression
10 years
Symptoms and signs
Time Frame: 10 years
Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients
10 years
genetic characteristics
Time Frame: 10 years
genetic characteristics of plasma cell disorder
10 years
cost-effectiveness
Time Frame: 10 years
cost-effectiveness of treatment in Thailand
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Collaborators

Faculty of Medicine Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2034

Study Completion (Estimated)

April 1, 2035

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 586/2564(IRB2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Need a consensus from colleagues

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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